The Food and Drug Administration (FDA) rejected eight new pharmaceuticals, including drugs to treat two conditions where only a limited number of medications are available – diabetes and obesity.
U.S. drug regulators rejected Biodel’s Linjeta, a fast-acting insulin, citing insufficient data. The agency said in order for the drug to be considered for approval again, two new clinical studies, one each in Type 1 and Type 2 diabetics, would have to be submitted. The FDA also had questions about how Linjeta was manufactured.
The agency also turned down Amylin Pharmaceuticals’ diabetes drug, a once-weekly injectable version of Bydureon (exenatide), requesting a thorough new study on QT rhythm, which would look at whether the drug is connected to irregular heartbeat in trial patients.
The FDA appears to be taking a much closer look at diabetes drugs in particular after the agency was criticized for its decision to approve GlaxoSmithKline’s Avandia (rosiglitazone). Avandia was later found to be linked to increased heart risks. In September, European regulators removed Avandia from the market, and the FDA voted to keep the drug available but put tight restrictions on prescriptions of Avandia.
An estimated 25 million Americans have diabetes and the number is expected to grow considerably as more and more people develop complications from obesity.
New drugs to help tackle the growing problem of obesity were also rejected by drug regulators last month. Arena Pharmaceuticals’ lorcaserin was quickly rejected by the panel because of concerns that the medication would put people at greater risk for brain or breast cancer. The agency also voted down Vivus’ diet drug Qnexa, asking the drug company to quantify what the risk of birth defects might be. The agency also raised questions about whether the slight increase in heart rate linked to the drug increases the risk of cardiovascular events such as heart attack or stroke.
The diet drug rejections came during the same month that the FDA ordered the removal of the weight loss medication Meridia (sibutramine) because studies show Meridia increases the risk of serious cardiovascular events.
Only one other weight loss drug has been approved by the FDA, orlistat, marketed in the U.S. as the prescription Xenical and the over-the-counter Alli. That drug carries a warning on its safety label of severe liver injury. There has not been a new prescription weight loss drug approved in the United States for more than a decade.